Ignite Creation Date:
2024-05-06 @ 3:56 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04801511
Status:
RECRUITING
Last Update Posted:
2021-03-17
First Post:
2021-03-11
Brief Title:
Preoperative IMRT With Concurrent High-dose Vitamin C and mFOLFOX6 in Locally Advanced Rectal Cancer
Sponsor:
Zhou Fuxiang
Organization:
Zhongnan Hospital
Study Overview
Official Title:
Safety and Efficacy of Preoperative IMRT Intensity-modulated Radiation Therapy With Concurrent High-dose Intravenous Vitamin C and mFOLFOX6 in Locally Advanced Rectal Cancer Patients a Prospective Study
Status:
RECRUITING
Status Verified Date:
2021-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CORT
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of preoperative chemoradiotherapy IMRT with concurrent high-dose intravenous vitamin C and mFOLFOX6 in locally advanced rectal cancer patients
Detailed Description:
Sixty patients with locally advanced rectal cancer cT3-4N0M0 cT1-4N1-2M0 12cm from anus will be enrolled and receive preoperative IMRT concurrent with high-dose intravenous vitamin C and 2-3 cycles of mFOLFOX6 chemotherapy and then after 4 weeks rest they will continue to complete 3 cycles of preoperative chemotherapy mFOLFOX6 Radical surgery will be performed at 10-12 weeks after IMRT
In this study we will evaluate the safety and effectiveness of the treatment method through the acute toxicity during CRT concurrent chemoradiotherapy PCR pathologic complete response rate sphincter preserving surgery rate 2-year survival rate and 2-year disease-free survival rate
In this study we will evaluate the safety and effectiveness of the treatment method through the acute toxicity during CRT concurrent chemoradiotherapy PCR pathologic complete response rate sphincter preserving surgery rate 2-year survival rate and 2-year disease-free survival rate
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None